Global Report: 'Bout Time

With widespread support from the pharmaceutical industry, the European Parliament has passed a resolution urging the European Union to work harder to combat the global problem of counterfeit medicines. And one Big Pharma company is changing the way it distributes medicines, saying its goal is to protect its supply chain from fakes.

The World Health Organization (WHO) estimates that counterfeits constitute 10 percent of the world's drug market; FDA believes the figure is even higher. Up to 70 percent of the antimalarial medicines sold in Cameroon appear to be fake, as do a quarter of all drugs used in developing countries—a figure that rises to an astonishing 50 percent in Pakistan and Nigeria. One fifth of the million annual deaths from malaria can be directly attributed to fake medicines, according to WHO. Although on a much smaller scale, counterfeit medicines are also a problem in the developed world: Earlier this year, 5,000 packs of counterfeit Tamiflu (oseltamivir) were seized in the United Kingdom.

Surprisingly, the European Union has no specific anti-counterfeiting measures for medicines. Parliament, in its resolution, expresses regret that the European Union is so late to enter the global fight against counterfeiting, particularly as the Internet and open borders exacerbate piracy.

Parliament is calling on the European Union to take stronger action against counterfeit medicines. It says the European Union should work to strengthen regulatory and quality control, particularly in those (developing) countries where resources are inadequate. Parliament, in its proposal, calls on the European Union to play a key role in promoting an international convention that would make counterfeiting, as well as receiving or distributing fake medicines, a criminal offense.

The resolution also emphasizes the importance of preventive measures, such as public-awareness campaigns about the dangers posed by fake drugs, and establishing formal structures and cooperation between authorities. The European Union is now committed to taking part in WHO's recently-established International Medical Products Anti-Counterfeiting Task Force.

Various parts of the industry have given Parliament's proposals their wholehearted support. At a joint European Parliament/ European Federation of Pharmaceutical Industries and Associations (EFPIA) press conference in Brussels, Thomas Zimmer, chair of EFPIA's anti-counterfeiting working group, said, "Counterfeit medicines is a growing global problem which requires a global solution. While [counterfeit drugs] have so far been rare in Europe, EFPIA stresses the importance of accessing medicines through certified distribution channels."

The European Association of Euro-Pharmaceutical Companies, a parallel traders group, is backing the resolution, as is the Active Pharmaceutical Ingredients Committee (APIC), the organization that represents manufacturers of active ingredients. With the manufacture of so many actives—particularly for generics—being outsourced to countries like India and China, there is potential for fake ingredients to enter the supply chain, too.

"The real fear lies in the possibility of a counterfeit ingredient finding its way into the supply chain of a commonly taken OTC medicine," says APIC's president Matt Moran. "One contaminated drum of API could potentially reach thousands of patients with disastrous consequences."

Meanwhile, Pfizer says it is taking greater control of its UK drug-distribution operations in an attempt to stamp out counterfeiting. It has signed an agreement with a single distributor, Unichem, and will no longer sell prescription medicines to UK wholesalers. In a letter to pharmacists, the company said its measures will "reduce the risk of counterfeit medicines by securing the distribution of the supply chain so that pharmacists and patients can be confident they will receive genuine Pfizer medicines."

The decision has been met with cynicism. The Medicines and Healthcare products Regulatory Agency says Pfizer's actions are commercially motivated. And Lloydspharmacy, one of the United Kingdom's largest pharmacy chains, is "outraged" at Pfizer's claim: "We believe this deal is not driven primarily by the need for action against counterfeits or concern for patients," said managing director Justin Ash. "It is a bitter pill that the world's largest drug manufacturer could be able to dictate the distribution economics and supply of medicines in the UK."

Ash added that his company believes Pfizer's move, by removing legitimate wholesalers from the system, may actually increase the likelihood of counterfeits. Unichem will now have to increase its twice-daily deliveries from 4,000 to 15,000 pharmacies. "Pfizer and Unichem will not know whether this works until it is too late," Ash said, "and people are unable to access the medicines they need."

Sarah Houlton is Pharmaceutical Executive's global correspondent. She can be reached at
sarah@owlmedia.co.uk